Intelligent Management Platform for Guiding Exercise Rehabilitation in Coronary Heart Disease Patients

NCT07259278 | Recruiting DMC

• 1 other identifier: 2024-I2M-C&T-B-040
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out if an artificial intelligence (AI)-enabled stratified management platform can help adults with coronary heart disease (CHD) better perform exercise rehabilitation and manage their health after being discharged from the hospital. The main questions it aims to answer are:

1. 1.Does using the AI platform lead to a greater improvement in exercise capacity (measured by peak oxygen consumption, VO2peak) after 3 months?
2. 2.Does the platform help increase daily physical activity, improve exercise adherence and motivation, and better control modifiable cardiovascular risk factors?
3. 3.Is guiding home-based exercise with this platform safe for low-risk CHD patients?
4. 4.Be randomly assigned to either use the AI platform or receive usual post-discharge care.
5. 5.Receive a personalized exercise prescription from a doctor before going home.
6. 6.If in the AI group: Use the smartphone app and wearable device to track health data for comprehensive post-discharge management, and receive reminders and immediate safety alerts.
7. 7.Attend a follow-up visit at 3 months for check-ups and tests, including an exercise test and health assessments.

Conditions

Secondary Prevention of Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (VO2peak)

  Peak oxygen consumption (VO2peak, mL∙kg-¹min-¹)

  From enrollment to the end of treatment at 3 months.

Secondary Outcomes (16)

• Change in 6-minute walk distance

  From enrollment to the end of treatment at 3 months

• Change in physical activity level (MET-min/week)

  From enrollment to the end of treatment at 3 months

• Change in average daily step count

  From enrollment to the end of treatment at 3 months

• Exercise adherence

  From enrollment to the end of treatment at 3 months.

• Composite endpoints

  From enrollment to the end of treatment at 3 months

Study Arms (2)

AI-Enabled Stratified Management Group

EXPERIMENTAL

Participants in the intervention group will receive comprehensive post-hospital rehabilitation management through an AI-based stratified management platform, utilizing a smartphone app and wearable device to track health data, deliver reminders and immediate safety alerts.

Combination Product: AI-Enabled Stratified Management System; Combination Product: Usual post-discharge care

Standard Post-Discharge Care Group

ACTIVE COMPARATOR

Participants in the control group will receive usual discharge protocol and personalized exercise prescription and goals from a specialist.

Combination Product: Usual post-discharge care

Interventions

AI-Enabled Stratified Management System COMBINATION_PRODUCT

Following discharge, participants in the AI-stratified management group will use an intelligent platform (smartphone app + wearable divice) for home-based exercise rehabilitation and comprehensive post-discharge care. Key features include: 1) Safety Monitoring \& Alerts: Real-time tracking of heart rate and other parameters via wristband triggers immediate safety warnings during exercise; 2) Holistic Risk Management: Integrated support for lifestyle modification, medication adherence, and control of cardiovascular risk factors; 3) Structured Engagement: Multi-channel reminders (messages, alarms, voice calls) for medications, exercise, and follow-ups to sustain adherence.

AI-Enabled Stratified Management Group

Usual post-discharge care COMBINATION_PRODUCT

Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies as well as a personalized exercise prescription.

AI-Enabled Stratified Management Group; Standard Post-Discharge Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CHD patients aged over 18 years;
• Stratified as low-risk for cardiovascular events during exercise and classified as low-risk according to the GRACE risk score.
• Ability of the patient or close relatives to use smartphones and applications;
• Willingness to participate and sign the informed consent form.

You may not qualify if:

• Residual stenosis of \>50% in the left main coronary artery, or \>70% stenosis in other major epicardial vessels;
• Planned coronary revascularization within the next 3 months;
• Acute myocardial infarction within the past 1 month;
• Severe cognitive impairment;
• Severely impaired exercise capacity.
• Advanced-stage malignancy;
• Life expectancy less than 3 months;
• Severe multi-organ failure;
• Other conditions deemed unsuitable for home-based exercise rehabilitation following assessment by a specialist rehabilitation physician.
• Refusal to provide written informed consent.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

Central Study Contacts

Prof. Gao, MD, PhD

CONTACT

010-88322413; sophie_gao@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years thereafter.
• Access Criteria: De-identified IPD and supporting documents will be made available upon reasonable request to the Principal Investigator (PI). Requests must include a methodologically sound proposal and intended use. Access will be granted at the discretion of the PI after review of the request.

Locations

CN (1)